Petroleum

Product NDC: 53329-068
11-digit product format: 533290068
Labeler code: 53329
Product ID: 53329-068_40c14f0d-cd27-922b-e063-6394a90a375e
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum
Dosage form: JELLY
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-01-01
Substance: PETROLATUM
Active strength: 1 g/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-068	53329-068-04	D	Discontinued by firm		2026-10-15
excluded package	package	53329-068	53329-068-44	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	53329-068-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	53329-068-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-068-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-068-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-068-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-068-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-068-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-068-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-068-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-068-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-068-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-068-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-068-44	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-068-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-068-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-068-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-068-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-068-44	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-068-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-068-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-068-44	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-068-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-068-44	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-068-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Petroleum
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204754	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
34f3581f-39ba-4f28-9237-52f3820ab4c0	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53329-068-01	2023-08-25	068 Curad Petroleum Jelly
53329-068-01	2023-08-25	068 Curad Petroleum Jelly
53329-068-04	2023-08-25	068 Curad Petroleum Jelly
53329-068-04	2023-08-25	068 Curad Petroleum Jelly
53329-068-16	2023-08-25	068 Curad Petroleum Jelly
53329-068-16	2023-08-25	068 Curad Petroleum Jelly
53329-068-44	2023-08-25	068 Curad Petroleum Jelly
53329-068-44	2023-08-25	068 Curad Petroleum Jelly
53329-068-96	2023-08-25	068 Curad Petroleum Jelly
53329-068-96	2023-08-25	068 Curad Petroleum Jelly
53329-068-01	2023-07-28	068 Curad Petroleum Jelly
53329-068-01	2023-07-28	068 Curad Petroleum Jelly
53329-068-04	2023-07-28	068 Curad Petroleum Jelly
53329-068-04	2023-07-28	068 Curad Petroleum Jelly
53329-068-16	2023-07-28	068 Curad Petroleum Jelly
53329-068-16	2023-07-28	068 Curad Petroleum Jelly
53329-068-44	2023-07-28	068 Curad Petroleum Jelly
53329-068-44	2023-07-28	068 Curad Petroleum Jelly
53329-068-96	2023-07-28	068 Curad Petroleum Jelly
53329-068-96	2023-07-28	068 Curad Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-068-01	Petroleum	28.4 g in 1 TUBE	JELLY	28.4	17
53329-068-01	Petroleum	1 in 1 BOX	JELLY	1	17
53329-068-04	Petroleum	118.29 g in 1 TUBE	JELLY	118.29	17
53329-068-16	Petroleum	5 g in 1 PACKET	JELLY	5	17
53329-068-44	Petroleum	113 g in 1 TUBE	JELLY	113	17
53329-068-96	Petroleum	144 in 1 CARTON	JELLY	144	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-068-01	GM - Gram	53329-068	2519f4ed-7728-4e58-bf47-9f93cb91d3ba	1	2021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]	7
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-068	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, LP]	16	Current NDC, Legacy NDC, 6 package rows	20250112_34f3581f-39ba-4f28-9237-52f3820ab4c0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novita Petrolatum Jelly Pink	PETROLATUM	Shield Line LLC	3e9d4992-5c1a-16d9-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Novita Pure Petrolatum Jelly	PETROLATUM	Shield Line LLC	3c55614f-932d-4898-e054-00144ff88e88	2025-08-18	Warnings	Exact identifier application number: M016
Arthcal Bioidentical Peach Cream	ARTHCAL BIOIDENTICAL PEACH CREAM	Beijing JUNGE Technology Co., Ltd.	3c77f787-b7dd-6813-e063-6394a90aa004	2025-08-16	Boxed warning, Warnings	Exact identifier application number: M016
Natureplex Diaper Rash	ZINC OXIDE	Natureplex LLC	41fe8db3-727c-4bbe-a5ea-62efee4b97b0	2025-08-15	Warnings	Exact identifier application number: M016
Aloe Vera Petrolatum Jelly	PETROLATUM	Shield Line LLC	fdf3b90e-a434-49b2-e053-6394a90ab175	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm PeriShield	ZINC OXIDE	Shield Line LLC	417f1541-d65a-4612-b96b-e6183fbef1f3	2025-08-15	Warnings	Exact identifier application number: M016
AmeriDerm Vitamin A D	WHITE PETROLATUM	Shield Line LLC	b73a8fc9-fa00-774a-e053-2995a90afd1e	2025-08-15	Warnings	Exact identifier application number: M016
Baby Petrolatum Jelly	PETROLATUM	SHIELD LINE LLC	35c163e6-ae41-2791-e054-00144ff8d46c	2025-08-15	Warnings	Exact identifier application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	Shield Line LLC	890ba245-ef37-4c62-ae82-980cb78acfb6	2025-08-15	Warnings	Exact identifier application number: M016
Earth Mama Eczema Cream	COLLOIDAL OATMEAL	Earth Mama Angel Baby, LLC	bd30b525-f68c-4786-9fbc-745e2634c6bb	2025-08-12	Warnings	Exact identifier application number: M016
Vitacilina Bebe Diaper Rash	ZINC OXIDE	Taisho Pharmaceutical California Inc.	6701e929-700e-40a4-9117-81e36577bfe1	2025-08-07	Warnings	Exact identifier application number: M016
Durma DynaGel	DURMA DYNAGEL	Dynarex Corporation	3bcbe314-98ca-78f1-e063-6394a90a13ad	2025-08-07	Warnings	Exact identifier application number: M016
Bath Bomb 2-pack (Lemon)	ALLANTOIN	Carolina Cannabis Creations LLC	08c7c313-cf36-fb46-e063-6294a90a7304	2025-08-06	Warnings	Exact identifier application number: M016
Earthmed Lip Balm Strawberry Rhubarb	ALLANTOIN	Earthmed LLC	3b54eea1-2e09-2ee1-e063-6294a90a52e5	2025-08-05	Warnings	Exact identifier application number: M016
ProCure Skin Repair Cream	DIMETHICONE 1.5%	Twin Med LLC	3ba3d3b3-ab13-ea80-e063-6394a90ad459	2025-08-05	Warnings	Exact identifier application number: M016
Earthmed FS Hand and foot	ALLANTOIN	Earthmed LLC	3ba592e9-2ef1-d20a-e063-6394a90a9bae	2025-08-05	Warnings	Exact identifier application number: M016
Earthmed FS massage oil	ALLANTOIN	Earthmed LLC	3ba64ad2-61b1-8021-e063-6294a90a7335	2025-08-05	Warnings	Exact identifier application number: M016
Petroleum Jelly	BABY PETROLEUM JELLY	NeilMed Pharmaceuticals Inc.	3b861e02-671a-c9e5-e063-6394a90a8d0f	2025-08-04	Warnings	Exact identifier application number: M016
Earthmed Sport massage oil	ALLANTOIN	Earthmed LLC	3b92e87d-ba8d-4bac-e063-6294a90a106e	2025-08-04	Warnings	Exact identifier application number: M016
EA EIGHT HOUR SKIN PROTECTANT	PETROLATUM	REVLON	b590991c-8ec8-67c2-e053-2a95a90a3acf	2025-08-01	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204754	petrolatum 100 % Topical Jelly	PSN	34f3581f-39ba-4f28-9237-52f3820ab4c0	17
204754	petrolatum 1 MG/MG Topical Ointment	SCD	34f3581f-39ba-4f28-9237-52f3820ab4c0	17
204754	petrolatum 100 % Topical Jelly	SY	34f3581f-39ba-4f28-9237-52f3820ab4c0	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-068-01	53329006801	1 TUBE in 1 BOX (53329-068-01) / 28.4 g in 1 TUBE	1 tube	2018-01-01	0000-00-00	No	No	Current
53329-068-04	53329006804	118.29 g in 1 TUBE (53329-068-04)	118.29 g	2019-02-21	0000-00-00	No	No	Current
53329-068-16	53329006816	5 g in 1 PACKET (53329-068-16)	5 g	2018-01-01	0000-00-00	No	No	Current
53329-068-44	53329006844	113 g in 1 TUBE (53329-068-44)	113 g	2018-01-01	2022-01-01	No	No	Current
53329-068-96	53329006896	144 PACKET in 1 CARTON (53329-068-96) / 5 g in 1 PACKET (53329-068-16)	144 packet	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
068 Curad Petroleum Jelly	Medline Industries, LP	2025-10-09	HUMAN OTC DRUG LABEL	17
ST COVID-POD (Saliva Collection Kit) - Asclemed USA, Inc.	Asclemed USA, Inc.	2020-09-23	HUMAN PRESCRIPTION DRUG LABEL	1